Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis

Randomized Control Trial of Mesenchymal Stem Cell Transplantation in Decompensated Liver Cirrhosis Resulted From Viral Hepatitis

There has been great interest in recent years to take advantage of stem cells to treat liver cirrhosis. Mesenchymal stem cells (MSC) has been shown to be safe and effective for liver diseases in some studies. Randomization controlled studies are needed to confirm the long term effect of MSC treatment for liver cirrhosis. This study aimed to investigate the safety and efficacy of mesenchymal stem cells in hepatitis B and C related liver cirrhosis patients.

This study is an open-label multicenter randomized control study. Patients with with decompensated cirrhosis will be randomly assigned to receive MSC treatment plus standard medical care(treatment）or standard medical care (control). Three times of MSC infusion (1x10E6 cells/kg body weight) via peripheral vein will be given to the experimental group (once in 4 weeks). The primary outcome is absolute change in liver function indexes and and scores. Secondary outcomes are cirrhosis-related complications, symptoms, life quality, and survival.

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: mesenchymal stem cell transplantation via peripheral vein; Other: mesenchymal stem cell

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Recruiting
      • Xijing Hospital of Digestive Disease, Xijing Hospital
      • Contact: Ying Han, Ph.D; Phone Number: 86-29-84771539; Email: hanying@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged 18-65 years
2. HBV -related liver cirrhosis
3. Child-Pugh score ≥7
4. With presentations of decompensation
5. Written consent

Exclusion Criteria:

1. Hepatocellular carcinoma or other malignancies
2. Severe problems in other vital organs(e.g.the heart,renal or lungs)
3. Pregnant or lactating women
4. Severe bacteria infection
5. Anticipated with difficulty of follow-up observation
6. Coinfection with HIV or other viral hepatitis.
7. Drug abuse or alcohol abuse
8. History of severe allergy to biological products
9. Other candidates who are judged to be not applicable to this study by doctors -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MSC group; mesenchymal stem cell transplantation via peripheral vein: 1x10E6 MSCs/kg body weight administered via peripheral vein at week 0, 4, 8.	Procedure: mesenchymal stem cell transplantation via peripheral vein; 1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8; Other: mesenchymal stem cell; mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
No Intervention: control; Standard medication for viral hepatitis and cirrhosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Change of liver functions as assessed by MELD score	Change of liver functions as assessed by MELD score (MELD, Model for End-Stage Liver Disease Score: MELD = 3.78×ln[serum bilirubin (mg/dL)] + 11.2×ln[INR] + 9.57×ln[serum creatinine (mg/dL)] + 6.43)	1 year
Safety: Adverse events as assessed according to CTCAE 4.03	Adverse events as assessed according to CTCAE 4.03	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival Benefit: Survival Rate at different time points	survival rate at different time points	1 year, 2 year and 5 years
Histological change of the liver: Histological scores assessed by liver biopsy	histological scores assessed by liver biopsy at baseline and after treatment	1 year, 2 year and 5 years
Clinical benefit: Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy	Incidences of cirrhosis-related complications such as GI bleeding, ascites, hepatorenal syndrome, hepatoencephalopathy	1, 2 and 5 years

Collaborators and Investigators

• Sponsor: Xijing Hospital of Digestive Diseases

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2017
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 5, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 11, 2018
• Last Update Submitted That Met QC Criteria: September 10, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Liver Cirrhosis; Mesenchymal Sem Cells
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: XJMSC0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No